Clinical trials: Pediatric Safety and Effectiveness
Bloody Diarrhea, STEC, Unspecified
Phase 2/3 Study to Evaluate PK, Safety & Efficacy of INM004 in STEC Positive Pediatric Patients for Prevention of HUS
The investigational medicinal product (IMP), INM004, proposes to neutralize the toxin in the bloodstream to prevent the interaction of the Stx with the specific receptor, by means of a polyclonal antibody to be administered upon…
- Conditions
- Bloody Diarrhea, STEC, Unspecified, Hemolytic-Uremic Syndrome, Pediatric Kidney Disease
- Trial name
- NCT04132375
- Testing
- INM004
- Where
- 7 sites in Argentina
- Volunteers
- 11 people
- Sponsor
- Inmunova S.A.
Epilepsy
Pediatric Epilepsy Trial in Subjects 1-24 Months
This study is being conducted to evaluate the effectiveness and safety of LAMICTAL added to the current therapy of pediatric patients age 1-24 months old with partial seizures.
- Trial name
- NCT00043875
- Testing
- lamotrigine
- Where
- 65 sites in United States, Australia and 12 more
- Volunteers
- 177 people
- Sponsor
- GlaxoSmithKline
Duchenne Muscular Dystrophy
A Gene Transfer Therapy to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) Following Therapeutic Plasma Exchange (Plasmapheresis) in Participants With Duchenne Muscular Dystrophy (DMD) and Pre-existing Antibodies to AAVrh74
This is a gene transfer therapy study evaluating the safety of and delandistrogene moxeparvovec dystrophin protein expression from delandistrogene moxeparvovec following therapeutic plasma exchange (plasmapheresis) in ambulatory…
- Trial name
- HORIZON (NCT06597656)
- Testing
- delandistrogene moxeparvovec, Plasmapheresis
- Where
- 3 sites in United States
- Volunteers
- 3 people
- Sponsor
- Sarepta Therapeutics, Inc.
Atopic Dermatitis
A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis
The reason for this study is to see if the study drug called baricitinib works and is safe in children and teenage participants with atopic dermatitis.
- Trial name
- BREEZE-AD-PEDS (NCT03952559)
- Testing
- Baricitinib, Topical corticosteroid
- Where
- 78 sites in Argentina, Australia and 15 more
- Volunteers
- 516 people
- Sponsor
- Eli Lilly and Company
Attention Deficit Hyperactivity Disorder
Dasotraline Pediatric ADHD Study
This is a 6 week efficacy and safety study of Dasotraline in subjects 6 to 12 years old with ADHD.
- Trial name
- NCT02428088
- Testing
- Dasotraline
- Where
- 43 sites in United States
- Volunteers
- 330 people
- Sponsor
- Sumitomo Pharma America, Inc.
Immune Thrombocytopenia, Treatment
Avatrombopag in the Treatment of Pediatric Immune Thrombocytopenia
To evaluate the safety and efficacy of avatrombopag in the treatment of pediatric primary immune thrombocytopenia in patients who have been treated with eltrombopag before and switched to avatrobopag because of poor efficacy…
- Trial name
- NCT06281327
- Testing
- Avatrombopag
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Dwarfism
Efficacy and Safety of rhGH (Jintropin®) in Pediatric Participants With ISS
Phase 1: To evaluate the safety and efficacy of 0.05mg/kg/d of rhGH (Jintropin®) in the treatment of children with idiopathic short stature (ISS) in 52 weeks.
- Trial name
- NCT03635580
- Testing
- Negative control
- Where
- 9 sites in China
- Volunteers
- 480 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Adolescent Lupus Nephritis, Pediatric Lupus Nephritis
Long-Term Voclosporin Treatment in Adolescent and Pediatric Subjects With Lupus Nephritis
The purpose of this study is to assess the long-term safety and tolerability of voclosporin for up to an additional 12 months following completion of treatment in the AUR-VCS-2020-03 study (VOCAL) in adolescent and pediatric…
- Trial name
- VOCAL-EXT (NCT05962788)
- Testing
- voclosporin
- Where
- 6 sites in United States, Colombia and 3 more
- Volunteers
- 4 people
- Sponsor
- Aurinia Pharmaceuticals Inc.
Influenza
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Chinese Pediatric Participants 1 to <12 Years of Age With Influenza Symptoms
The purpose of this study is to evaluate the safety of a single dose baloxavir marboxil compared with 5 days of oseltamivir administered twice a day (BID) in Chinese pediatric participants aged 1 to < 12 years with influenza…
- Trial name
- NCT06774859
- Testing
- Baloxavir Marboxil, Oseltamivir
- Where
- 16 sites in China
- Volunteers
- 100 people
- Sponsor
- Hoffmann-La Roche
Molybdenum Cofactor Deficiency, Type A
Safety & Efficacy Study of ORGN001 (Formerly ALXN1101) in Pediatric Patients With MoCD Type A Currently Treated With rcPMP
This study will include a screening period, a 6-month treatment period, followed by long-term extension period expected to last approximately 72 months.
- Trial name
- NCT02047461
- Testing
- ORGN001 (formerly ALXN1101)
- Where
- 6 sites in United States, Australia and 3 more
- Volunteers
- 8 people
- Sponsor
- Origin Biosciences
Developmental and Epileptic Encephalopathy
A Clinical Trial of CAP-002 Gene Therapy in Pediatric Patients With Syntaxin-Binding Protein 1 (STXBP1) Encephalopathy
The goal of this clinical trial is to learn about the safety of CAP-002 gene therapy in children with Syntaxin-Binding Protein 1 (STXBP1) Encephalopathy.
- Trial name
- NCT06983158
- Testing
- gene therapy
- Where
- 4 sites in United States
- Volunteers
- 1 people
- Sponsor
- Capsida Biotherapeutics, Inc.
Rhinitis, Allergic, Perennial
Study Of Perennial Allergic Rhinitis In Pediatrics
To verify of cetirizine dry syrup to ketotifen dry syrup in the change of total nasal symptom score (TNSS) over the total treatment period from the score of the baseline assessment period
- Trial name
- NCT00253058
- Testing
- Cetirizine Dry Syrup
- Volunteers
- 286 people
- Sponsor
- GlaxoSmithKline
B-cell Acute Lymphoblastic Leukemia, Relapsed B-cell Acute Lymphoblastic Leukemia
Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients
This was a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of an experimental therapy called CTL019 T-cells in pediatric patients with B-cell acute lymphoblastic leukemia, who were…
- Conditions
- B-cell Acute Lymphoblastic Leukemia, Relapsed B-cell Acute Lymphoblastic Leukemia, Refractory B-cell Acute Lymphoblastic Leukemia
- Trial name
- ENSIGN (NCT02228096)
- Testing
- CTL019 T-cells
- Where
- 13 sites in United States
- Volunteers
- 75 people
- Sponsor
- Novartis Pharmaceuticals
Lennox Gastaut Syndrome (LGS)
A Study of Soticlestat as an Add-on Therapy in Children, Teenagers, and Adults With Lennox-Gastaut Syndrome
The aims of the study are: to learn if soticlestat, when given as add-on therapy, reduces the number of major motor drop seizures in children, teenagers, and adults with Lennox-Gastaut Syndrome.
- Trial name
- NCT04938427
- Testing
- Soticlestat
- Where
- 98 sites in United States, Australia and 16 more
- Volunteers
- 270 people
- Sponsor
- Takeda
Influenza
A Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Suraxavir Marboxil for Suspension
This study will evaluate the safety, efficacy and pharmacokinetics of Suraxavir Marboxil compared with oseltamivir in Pediatric Patients (2 to <12 Years) with Uncomplicated Influenza.
- Trial name
- NCT07113392
- Testing
- Suraxavir Marboxil, Oseltamivir
- Volunteers
- 144 people
- Sponsor
- Jiangxi Kvvit Pharmaceutical Co., Ltd.
Fever
Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients
The primary objective of the study is to determine the superiority of a single dose of intravenous ibuprofen compared to acetaminophen for the treatment of fever during the first two hours of treatment.
- Trial name
- NCT01002573
- Testing
- ibuprofen, acetaminophen
- Where
- 17 sites in United States
- Volunteers
- 118 people
- Sponsor
- Cumberland Pharmaceuticals
Crohn Disease
A Study of Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease
The purpose of study is to test the effect of an experimental medication GED-0301(mongersen) and evaluate its safety in patients (≥ 12 years of age) with active Crohn's disease.
- Trial name
- NCT02974322
- Testing
- GED-0301
- Where
- 311 sites in United States, Australia and 28 more
- Sponsor
- Celgene
Sickle Cell Disease, Acute Chest Syndrome
Efficacy and Safety of Tocilizumab for Acute Chest Syndrome Treatment in Patients With Sickle Cell Disease
The purpose of this study is to determine whether a single infusion of tocilizumab is effective in reducing the time to successful weaning from both supplemental oxygen and any respiratory support, in pediatric and adult patients…
- Trial name
- TOCIACS (NCT06818266)
- Testing
- Tocilizumab (RoActemra®, 20 mg/mL).
- Where
- France
- Volunteers
- 130 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Attention Deficit Disorder With Hyperactivity
Efficacy, Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD
This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.
- Trial name
- NCT00151970
- Testing
- Methylphenidate Transdermal System, Concerta
- Volunteers
- 128 people
- Sponsor
- Noven Therapeutics
Pediatric Venous Thromboembolism
Rivaroxaban in Pediatric Patients With DVT
Prospective interventional randomized controlled trial to assess safety and efficacy of rivaroxaban in pediatric patients with acute deep venous thrombosis.
- Trial name
- NCT07618988
- Testing
- Rivaroxaban, Enoxaparin, Heparin
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Ain Shams University
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